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Janethe de Oliveira Pena

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Articles 18
Citations 555
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Recent Articles
1.
Montani D, McLaughlin V, Gibbs J, Gomberg-Maitland M, Hoeper M, Preston I, et al.
Am J Respir Crit Care Med . 2025 Mar; PMID: 40035659
Objectives: To evaluate the effect of genetic variant status on sotatercept efficacy and effect of sotatercept treatment on biomarkers in pulmonary arterial hypertension Methods: PULSAR (NCT03496207) was a phase 2,...
2.
Preston I, Badesch D, Ghofrani H, Gibbs J, Gomberg-Maitland M, Hoeper M, et al.
Eur Respir J . 2025 Feb; PMID: 39978862
Background: SOTERIA (NCT04796337) is an ongoing open-label study evaluating long-term safety, tolerability, and efficacy of sotatercept in participants with pulmonary arterial hypertension (PAH). Methods: Eligible adults with PAH on stable...
3.
Hoeper M, Gomberg-Maitland M, Badesch D, Gibbs J, Grunig E, Kopec G, et al.
Eur Respir J . 2025 Jan; PMID: 39884760
Introduction: Pulmonary arterial hypertension (PAH) is a progressive disease associated with significant morbidity and mortality. Sotatercept is a first-in-class activin signalling inhibitor that acts to restore the balance between the...
4.
Ait-Oudhia S, Jaworowicz D, Hu Z, Gaurav M, Barcomb H, Hu S, et al.
Clin Pharmacol Ther . 2024 Dec; 117(3):798-807. PMID: 39668469
Sotatercept is a breakthrough, first-in-class biologic, recently approved by the Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). Exposure-response (E-R) analyses and pharmacokinetic/pharmacodynamic (PK/PD) modeling...
5.
Gomberg-Maitland M, Badesch D, Gibbs J, Grunig E, Hoeper M, Humbert M, et al.
J Heart Lung Transplant . 2024 Dec; PMID: 39645016
Background: This analysis examined the effects of the activin signaling inhibitor, sotatercept, in pulmonary arterial hypertension (PAH) subgroups stratified by baseline cardiac index (CI). Methods: Pooled data from PULSAR (N ...
6.
Ait-Oudhia S, Jaworowicz D, Hu Z, Bihorel S, Hu S, Balasubrahmanyam B, et al.
CPT Pharmacometrics Syst Pharmacol . 2024 May; 13(8):1380-1393. PMID: 38812074
Sotatercept is a breakthrough, first-in-class biologic, that is FDA-approved for the treatment of pulmonary arterial hypertension (PAH). A population pharmacokinetic (PopPK) model was developed using data from two phase 1...
7.
Waxman A, Systrom D, Manimaran S, de Oliveira Pena J, Lu J, Rischard F
Circ Heart Fail . 2024 Apr; 17(5):e011227. PMID: 38572639
Background: This study aims to assess the impact of sotatercept on exercise tolerance, exercise capacity, and right ventricular function in pulmonary arterial hypertension. Methods: SPECTRA (Sotatercept Phase 2 Exploratory Clinical...
8.
Liao K, Mackenzie H, Ait-Oudhia S, Manimaran S, Zeng Y, Akers T, et al.
Clin Pharmacol Ther . 2023 Nov; 115(3):478-487. PMID: 38012534
Sotatercept, a soluble fusion protein comprising the extracellular domain of activin receptor type IIA linked to the Fc portion of human IgG1, is a first-in-class activin signaling inhibitor under development...
9.
McLaughlin V, Alsumali A, Liu R, Klok R, Martinez E, Nourhussein I, et al.
Adv Ther . 2023 Oct; 41(1):130-151. PMID: 37851297
Introduction: Pulmonary arterial hypertension (PAH) is a rare, progressive disease associated with significant morbidity and mortality. The phase 3 STELLAR trial tested sotatercept plus background therapy (BGT) versus placebo plus...
10.
Souza R, Badesch D, Ghofrani H, Gibbs J, Gomberg-Maitland M, McLaughlin V, et al.
Eur Respir J . 2023 Sep; 62(3). PMID: 37696565
Background: In the phase 3 STELLAR trial, sotatercept, an investigational first-in-class activin signalling inhibitor, demonstrated beneficial effects on 6-min walk distance and additional efficacy endpoints in pre-treated participants with pulmonary...